Fluorouracil

Product NDC: 68001-266
Requested package NDC: 68001-266-32
11-digit product format: 680010266
Labeler code: 68001
Product ID: 68001-266_926a894d-ae3e-4a83-992a-045c1795c74f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluorouracil
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: BluePoint Laboratories
Application: ANDA040798
Marketing category: ANDA
Marketing start: 2014-12-16
Marketing end: 0000-00-00
Substance: FLUOROURACIL
Active strength: 50 mg/mL
Pharmacologic classes: Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68001-266	68001-266-32	D	Discontinued by firm		2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040798-001	FLUOROURACIL	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP		2007-04-26
A040798-002	FLUOROURACIL	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION			2007-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A040798-001	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP		2007-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION			2007-04-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP		2007-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION			2007-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP		2007-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION			2007-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP		2007-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION			2007-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP		2007-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION			2007-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040798-001	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040798-002	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	RS	2007-04-26	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A040798-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040798-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040798-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040798-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040798-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040798-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040798-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040798-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040798-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040798-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040798-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040798-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040798-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040798-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040798-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040798-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040798-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040798-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040798-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040798-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040798-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040798-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040798-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040798-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040798-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040798-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040798-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040798-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040798-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040798-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040798-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040798-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040798-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040798-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040798-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040798-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040798-002	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040798-001	AP	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040798-002	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040798-001	AP	1	`87673890dc5c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-266-24	ML - Milliliter	68001-266	4dec7e4a-d814-4d2f-a9f8-14723f4970e0	1	2015-04-03
68001-266-27	ML - Milliliter	68001-266	a70b193d-31eb-43da-ac6b-11a6df4a2e1c	1	2015-04-03
68001-266-28	ML - Milliliter	68001-266	7ab10dfc-239d-4617-9200-c6e627219dde	1	2015-04-03
68001-266-29	ML - Milliliter	68001-266	1dc7e1cc-cbcb-49b0-97ac-dfeff23fb951	1	2015-04-03
68001-266-30	ML - Milliliter	68001-266	0f162c72-f59f-4593-8468-b7fa7c838254	1	2015-04-03
68001-266-31	ML - Milliliter	68001-266	5d99fb5a-f2fe-4c7b-b601-ca635068b38a	1	2015-04-03
68001-266-32	ML - Milliliter	68001-266	c68d07eb-65d9-42ed-aec3-a241ec3649de	1	2015-04-03
68001-266-33	ML - Milliliter	68001-266	7739cc63-3a3d-450e-946a-c95a06af0418	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUOROURACIL	ACTIVE INGREDIENT	U3P01618RT	FLUOROURACIL INJECTION, SOLUTION [BLUEPOINT LABORATORIES]	3
Fluorouracil	ACTIVE INGREDIENT	U3P01618RT	FLUOROURACIL INJECTION, SOLUTION [BLUEPOINT LABORATORIES]	3
FLUOROURACIL	ACTIVE MOIETY	U3P01618RT	FLUOROURACIL INJECTION, SOLUTION [BLUEPOINT LABORATORIES]	3
Fluorouracil	ACTIVE MOIETY	U3P01618RT	FLUOROURACIL INJECTION, SOLUTION [BLUEPOINT LABORATORIES]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FLUOROURACIL INJECTION, SOLUTION [BLUEPOINT LABORATORIES]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FLUOROURACIL INJECTION, SOLUTION [BLUEPOINT LABORATORIES]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	FLUOROURACIL INJECTION, SOLUTION [BLUEPOINT LABORATORIES]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	FLUOROURACIL INJECTION, SOLUTION [BLUEPOINT LABORATORIES]	3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluorouracil	FLUOROURACIL	Accord Healthcare, Inc.	8eff167f-203a-4a81-b2fc-d8773bc3555e	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040798 application number: ANDA040798

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3P01618RT	FLUOROURACIL	51-21-8	FLUOROURACIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-266-32	68001026632	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68001-266-32) > 100 mL in 1 VIAL, PHARMACY BULK PACKAGE (68001-266-33)	2014-12-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluorouracil	BluePoint Laboratories \| Intas Pharmaceuticals Ltd	2020-09-04	HUMAN PRESCRIPTION DRUG LABEL	6
Fluorouracil	BluePoint Laboratories \| Intas Pharmaceuticals Ltd	2016-11-30	HUMAN PRESCRIPTION DRUG LABEL	4